Apparatus and process for producing CO2 enriched medical foam

ABSTRACT

The present invention provides an apparatus for producing medical foam for wound care or hair stimulation. The apparatus includes a foam generation unit having a fluid reservoir, a fluid delivery line and a foam generation tip. The apparatus also includes a compressed gas unit having at least one container of compressed gas, a source of electric power, and a gas regulator valve. A supply of wound care or hair stimulating solution is communicably connected to the foam generation tip such that when the apparatus is operated medical foam is produced by the foam generator tip.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/509,459 filed Oct. 8, 2014, which is currently pending, which is acontinuation of U.S. patent application Ser. No. 13/068,680 filed May17, 2011, issued as U.S. Pat. No. 8,876,749, which is a continuation inpart of U.S. patent application Ser. No. 12/652,845 filed Jan. 6, 2010,which is abandoned, which is a continuation-in-part U.S. patentapplication Ser. No. 12/210,368 filed Sep. 15, 2008, which is abandoned,which is continuation-in-part of U.S. patent application Ser. No.11/945,674 filed Nov. 27, 2007, which is U.S. Pat. No. 7,543,760, whichclaims the benefit of U.S. Provisional Patent Application Ser. No.60/867,323 filed Nov. 27, 2006, the disclosures of which areincorporated herein by reference in their entirety.

FIELD OF THE INVENTION

This invention relates to an apparatus and process for producing CO₂enriched medical foam for use in wound care and hair growth stimulation.

BACKGROUND OF THE INVENTION

The present invention utilizes the Venturi effect to produce medicalgrade foam comprising CO₂ for use in applications such as wound care andhair growth stimulation. The apparatus of the present invention issimple to manufacture and use because it does not require an impellerand incorporated fan with a foam generator in order to create anddispense the foam.

The Venturi effect is an example of Bernoulli's principle, in the caseof incompressible fluid flow through a tube or pipe with a constrictionin it. The fluid velocity must increase through the constriction tosatisfy the equation of continuity, while its pressure must decrease dueto conservation of energy: the gain in kinetic energy is supplied by adrop in pressure or a pressure gradient force.

The limiting case of the Venturi effect is choked flow, in which aconstriction in a pipe or channel limits the total flow rate through thechannel because the pressure cannot drop below zero in the constriction.Choked flow is used to control the delivery rate of water and otherfluids through spigots and other types of valves. The portable apparatusof the present invention utilizes a source of compressed gas, namelyCO₂, to produce the desired pressure and airflow for the effectivecreation of medical foam, which foam is, in turn, used for wound careand hair growth stimulation. To date, medical foam has been usedstrictly in sclerosing applications, wherein blood vessels aredestroyed. Medical foam has not been previously utilized in woundtherapy or hair growth techniques wherein cell growth is encouraged. CO₂enriched foam has certainly not been put to such uses.

SUMMARY OF THE INVENTION

The present invention provides for a novel apparatus for producingmedical foam as well as a process for utilizing such foam in wound careand hair growth applications. One embodiment in the present inventionfeatures an apparatus for producing medical foam comprising (i) a foamgeneration unit having a fluid reservoir, a fluid delivery line and afoam generation tip; and (ii) a compressed gas unit having at least onecontainer of compressed gas, a source of electric power and the gasregulator valve.

The fluid reservoir contains a medical solution for producing the foam.The compressed gas is any suitable compressed gas. Suitable compressedgases may preferably include carbon dioxide, atmospheric air, helium, ormixtures thereof. The compressed gas is contained in one or morecompressed gas containers. The apparatus has a source of electric powerthat may be delivered by batteries providing between about 3-24 volts.The apparatus also has a foam generation tip that includes a membraneproviding a surface for the formation of medial foam. In a preferredembodiment, the gas regulator valve is an electronically activatedsolenoid. Additionally preferred, the gas regulator valve is anelectronically activated solenoid controlled by a pressure activationswitch or actuator. The pressure switch activates the solenoid whendepressed.

In one embodiment, the present invention utilizes an air delivery systemwhereby the air is delivered by compressed gas. Any compressed gas canbe used. Preferably, the compressed gas is selected from compressedambient air, carbon dioxide, helium, oxygen, or combinations thereof.Carbon dioxide is especially preferred for using the medical foamproduced by the apparatus in wound treatment and hair growthstimulation.

In another embodiment, the apparatus of the present invention includescompressed air storage, with a hose or other acceptable transportmechanism to deliver the compressed gas to the foam generation tip orany other receptacle. The foam generation tip includes a novelarrangement by which compressed air enters a first end of the foamgeneration tip through an air inlet. The resultant pressure producedwithin the foam generation tip draws medical solution into the interiorof the tip through a second inlet. The compressed air continues totravel towards the second end of the foam generation tip onto which amembrane is affixed. The membrane provides a surface at which themedical solution mixes with the compressed air and the medical solutionfoams. The compressed air passes through the membrane and lifts thefoams off the membrane outward from the foam generation tip. Thus, thesolution, now foamed by the compressed gas, can be delivered and appliedto a wound or area of the body where hair growth is desired.

In another embodiment, a user will utilize two separate units of theapparatus wherein a first unit includes at least one compressed aircylinder and a valve for controlling the release of compressed air fromthe cylinder. In one embodiment, the valve for controlling the releaseof compressed air is an electronic solenoid.

The present invention also relates to methods of medical treatment. Inone embodiment the invention is a method for providing CO₂ enriched foamand applying such foam to a wound comprising the steps of: (i) providinga portable CO₂ apparatus, (ii) providing a container with a medicalsolution, the container having an entrance, an exit and a release meansregulating the exit; (iii) attaching a medically acceptable directionaldevice from the apparatus to the entrance of the container; (iv)initiating an actuator of the apparatus to release CO₂; (v) activatingthe release means to produce a medical foam containing CO₂; and (vi)applying the medical foam to a wound to attract oxygen to the wound andthereby promote healing. In medical uses, CO₂ is used because it issafer and has less complications than air or oxygen in the same uses.CO₂ diffuses more naturally in body tissues and is absorbed in the bodymore rapidly and with less side effects. Medical foam produced in thismanner may alternatively be applied to a skin surface of the human bodyto stimulate hair growth.

In a preferred embodiment, the CO₂ gas that is expelled from theapparatus will ultimately be used for foaming of medical solutions toproduce a CO₂ enriched foam for the healing of ulcerations. Thesesolutions may include, but would not be limited to saline, aloe,Amerigele ® , microbial agents, and surfactants. CO₂ is used to aeratethe solution and subsequently produce a medical foam for particular usein the field of wound and ulceration treatment. CO₂ enriched foam withthe addition of medically appropriate solutions and surfactants will aidin the debridement of a wound, as well as, more efficient and more rapidhealing of the affected area by drawing oxygen to that area.

The apparatus used in the present invention is portable, compact, andelectronic, which makes it convenient for various portable medical usesincluding military field use. The apparatus is also well suited for anyother use requiring CO₂ for its performance, such ascompartmentalization, aid in ulcer healing, and aid in increasingfollicle hair stimulation to promote hair growth. The apparatus of thepresent invention can also be adapted for dispensing other gases underthe same nature, such as oxygen, helium, or any other gas needed to becontained in a compact, portable delivery system. In a preferredembodiment, the present invention is completely battery operated.

The invention can be used to provide CO₂ or like gases to one syringe,two syringes with a stopcock connector, or any container that can houseor store the CO₂ before using it to aid in ulcer healing, and/or inincreased follicle hair stimulation to aid in hair growth.

The invention can deliver CO₂ from an adjustable port that controls thepsi from 0 psi to 120 psi.

Previous methods utilizing large CO₂ tanks and regulators are dangerousbecause of the risk of a seal, valve, or part malfunction causing aprojectile in a medical setting. The present invention is safer as iteliminates this possibility of malfunction.

The invention requires very little space to store, as opposed to thecumbersome existing tank systems and is much easier to use, with a pushbutton actuator to initiate operation. The present invention is muchless expensive than current CO₂ tank systems.

Acquisition of the CO₂ in the present invention now requires onlycartridges which can be delivered in a small box. The current tanksrequire filling at a filling station which involves the transport of alarge quantity of CO₂ which could also result in an explosion in theevent of a motor vehicle crash.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Other objects, features and advantages will occur from the followingdescription of a preferred embodiment and the accompanying drawings, inwhich:

FIG. 1 is a side perspective and partly schematic view of an apparatusincluding compressed gas (CO₂) cylinders and a solenoid of the presentinvention;

FIG. 2 is a perspective view of the foam generating tip and medicalsolution reservoir;

-   -   FIG. 3 is a close-up view of the foam generating tip shown in        FIG. 2;    -   FIG. 4 is a schematic front view of an alternative compressed        gas unit enclosed in a housing;    -   FIG. 5 depicts a schematic layout of the components of the        compressed gas unit of FIG. 4.

In FIG. 1 compressed gas unit 1 comprises solenoid 55 with at least onecompressed gas (CO₂) cylinder 27. In one embodiment, compressed gascylinder 27 is 25 g or larger. Compressed gas cylinder 27 is securedinto position to unit 1 by means of cylinder cartridge puncture valve 26and a fitting 74. In a preferred embodiment, cylinder cartridge puncturevalve 26 has a mechanism for piercing cylinder 27, as is known, andholding or securing said cylinder in place. Compressed air is deliveredto solenoid 55 from compressed gas cylinder 27 through cylindercartridge puncture valve 26 and a channel 73 of fitting 74. Compressedgas unit 1 has at least one battery 65, held in place by battery holder42, for providing electrical power by which solenoid 55 may be activatedand then regulated by a pressure activation switch or actuator 37.Battery 65 supplies power to solenoid 55 through switch wire assembly23, which is connected to activation switch 37. This switch is mountedto a pressure nut 32 carried on threaded conduit 38. Compressed air unit1 has electrical wiring 39 for providing necessary electricity fromswitch 37 to solenoid 55. Unit 1 also comprises a black rock regulator140, which is controlled by secondary regulator adjustment knob 30 whensolenoid 55 is activated. Black rock regulator 140 is communicablyconnected to unit 1 by an elbow pipe 40. The elbow pipe includes athreaded vertical conduit segment 41 joined to regulator 140 through aconnector nut and a threaded horizontal conduit 38, which is engaged bypressure nut 32.

Compressed gas cylinder 27 is secured to unit 1 by cartridge puncturevalve 26 as is commonly known. In one embodiment, compressed gascylinder 27 is a 25 g cylinder. Compressed air leaves black rockregulator 140 through a 10/32″ hose port 12 b and flows through a hosejunction 22, by means of ⅛″ pressure hose 54, until reaching the 10/32″hose port 12 affixed to solenoid 55. From hose port 12, the compressedair enters solenoid 55. Compressed air unit 1 also has an outlet airport 25, which is connected to solenoid 55 through intermediate 10/32″hose port 12 a for transporting compressed gas, namely CO₂, fromsolenoid 55 in compressed gas unit 1 to foam generation unit 2, FIG.whenever the solenoid is opened. Outlet gas may be monitored withpressure gauge 52 connected to hose junction 22 through a conduit 45having threads 46. The threaded end of conduit 45 interengages a nut 48carried by hose junction 22.

In certain embodiments a second compressed gas cylinder 28, featuring a12 g or 16 g compressed gas cylinder, may be used in addition to or inlieu of gas cylinder 27. In still other embodiments a larger compressedgas cylinder and expansion chamber may be substituted for the gascartridges previously described in accordance with the invention. Thesize and number of compressed gas containers are not limitations of theinvention.

In FIG. 2, a CO₂ enriched foam generating unit 2 features a micro hose256 for receiving compressed gas from unit 1. Compressed CO₂ leavingunit 1 via outlet air port 25 enters unit 2 via micro hose 256.Compressed gas passes through air hose inlet 230 and enters a foamgeneration tip 280.

As shown in FIG. 3 foam generation tip 280 also includes foam solutiondelivery line 227 that has an outlet 220 for delivering foam solutioninto upper chamber 240. This solution may include any of varioussolutions such as, but not limited to various wound wash solutions,saline, aloe, microbial agents and surfactants which are appropriate fortreating wounds and ulcerations. For example, Amerigel® solution may beeffectively utilized as the foam solution. Solutions for stimulatinghair growth include monoxidil marketed under the brand name Rogaine®. Ina preferred embodiment, medical solution from solution reservoir 290,FIG. 2, travels up needle 241 and hub 246 when compressed gas enters tipassembly 280 through inlet 230 after being actuated and released fromunit 1. Compressed gas entering tip assembly 280 imparts negativepressure on solution in reservoir 290 and draws solution through needle241 and into tip solution inlet 225 (FIGS. 2 and 3) through hose 216 dueto the Venturi effect. Stopcock 255 is used to regulate or stop flow ofsolution from reservoir 290. Solution enters solution delivery line 227from solution line 216. Compressed gas traveling from lower chamber 235to upper chamber 240 creates negative pressure inside the foamgeneration tip 280, such that medical foam solution exiting outlet 220mixes with compressed CO₂ and forms CO₂ enriched medical foam that formson membrane 215. The force of the compressed gas traveling through foamgeneration tip 280 and exiting through membrane 215 lifts medicalfoam/foams outward from membrane 215 and projects the foam into the foamdispensing port 270. The medical foam then exits tip assembly 280through syringe hub 260 and is directed onto a wound or ulcerationrequiring treatment. Specifically, CO₂ enriched foam may be applieddirectly to a wound or ulceration. The CO₂ attracts oxygen to thewound/ulceration, which promotes healing. This is an unexpectedbeneficial result as, to date, the use of medical foams has been largelylimited to sclerotherapy wherein blood vessels/tissue are destroyed. CO₂enriched foam produced in the foregoing manner may alternatively be usedto stimulate hair follicle growth.

FIGS. 4 and 5 depict an alternative embodiment of a compressed gas unitla wherein various components of the gas unit are enclosed in a housing75 a. The components of unit 1 a are designated by reference numeralsthat correspond to those of the previously described embodiment andfurther include “a” designations. In particular, a CO₂ cartridge 27 a isconnected by a puncture valve 26 a to a regulator 140 a. The regulatoris controlled by an adjustment knob 30 a. Regulator 140 a is connectedthrough a conduit 54 a to both a pressure gauge 52 a and a solenoid 55a. More particularly, gauge 52 a is connected to a coupling 48 a.Solenoid 55 a is powered by a battery 65 a, which is itself held inplace within the housing 75 a by a holder 42 a. A user accessible luerfitting 25 a is communicably connected to solenoid 55 a and extendsexteriorly of housing 75 a.

Unit 1 a is activated to open solenoid 55 a by engaging switch 37 a. Thecompressed gas unit operates in a manner analogous to that previouslydescribed to provide compressed CO₂ from cartridge 27 a through luerfitting 25 a to an attached foam generating tip as depicted in FIGS. 2and 3.

From the foregoing it may be seen that the apparatus and method of thisinvention provides for a novel and beneficial means for wound care andhair growth treatment. While this detailed description has set forthparticularly preferred embodiments of the apparatus of this invention,numerous modifications and variations of the structure of thisinvention, all within the scope of the invention, will readily occur tothose skilled in the art. Accordingly, it is understood that thisdescription is illustrative only of the principles of the invention andis not limitative thereof.

Although specific features of the invention are shown in some of thedrawings and not others, this is for convenience only, as each featuremay be combined with any and all of the other features in accordancewith this invention.

Other embodiments will occur to those skilled in the art and are withinthe following claims:

What is claimed is:
 1. A method of medical treatment, said methodcomprising: providing a portable compressed CO₂ unit adapted forselective attachment of a compressed gas cylinder thereto; selectivelysecuring the compressed gas cylinder containing compressed CO₂ to thecompressed CO₂ unit; providing a reservoir with a medical therapysolution; communicably interconnecting the reservoir with the compressedCO₂ unit; initiating the compressed CO₂ unit to deliver compressed CO₂from the compressed gas cylinder to impart negative pressure on themedical therapy solution in the reservoir such that the medical therapysolution is drawn from the reservoir for mixing with the compressed CO₂to generate a CO₂ enriched medical therapy solution; and applying theCO₂ enriched medical therapy solution for medical treatment.
 2. A CO₂enriched medical therapy solution made in accordance with the methodcomprising the steps of: providing a portable compressed CO₂ unitadapted for selective attachment of a compressed gas cylinder thereto;selectively securing the compressed gas cylinder containing compressedCO₂ to the compressed CO₂ unit; providing a reservoir with a medicaltherapy solution; communicably interconnecting the reservoir with thecompressed CO₂ unit; and initiating the compressed CO₂ unit to delivercompressed CO₂ from the compressed gas cylinder to impart negativepressure on the medical therapy solution in the reservoir such that themedical therapy solution is drawn from the reservoir for mixing with thecompressed CO₂ to generate a CO₂ enriched medical therapy solution.